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The Last Two Years: A Summary of 2014-2015 Office of Prescription Drug Promotion (OPDP) Enforcement and Relevant FDA Guidance

USA - March 1 2016 The past two years have created a bit of uncertainty for life sciences promotional review professionals. With fewer enforcement letters, high-profile…

Jennifer A. Romanski.

First half of 2013: ten FDA enforcement letters

USA - July 15 2013 The Office of Prescription Drug Promotion ("OPDP") of the Federal Drug Administration ("FDA") issued ten enforcement letters in the first six months…

The Office of Inspector General releases 2014 Work Plan

USA - March 6 2014 The Office of Inspector General (OIG) has released its 2014 Work Plan. The Work Plan summarizes activities OIG plans to pursue with respect to the U…

Untruthful or misleading prescription drug promotion, the subject of OPDP new e-learning course

USA - October 30 2013 In May 2010, the the Food and Drug Administration's (FDA) Office of Prescription Drug Promotion(OPDP) (formerly the Division of Drug Marketing…

Distributing scientific and medical publications on unapproved new uses is the subject of revised FDA draft guidance

USA - March 5 2014 On February 28, 2014, the U.S. Food and Drug Administration (FDA) released the revised draft guidance entitled "Distributing Scientific and Medical…